Researchers seeking people with progressive MS for nationwide trial of oral therapy
Summary: Investigators are recruiting for a phase II clinical trial of ibudilast (MN-166, MediciNova, Inc.), an oral agent, in 250 people with progressive forms of MS. The study, called the SPRINT-MS trial, is principally funded by the National Institutes of Neurological Diseases and Stroke (NINDS), with additional support by MediciNova, the company that will supply ibudilast, and the National MS Society. The study will be conducted through the NeuroNEXT Network, a clinical trials initiative of the National Institutes of Health. Robert Fox, MD (Cleveland Clinic Foundation) is the principal investigator.
Rationale: Among other actions, ibudilast inhibits an enzyme called phosphodiesterase, and has been shown to protect brain tissue in animal models. . While considered a “New Chemical Entity” in the United States and Europe, ibudilast is marketed in Japan and Korea to treat asthma and symptoms from cerebrovascular disorders. It is being investigated in the U.S. for its potential to treat drug addiction and now, for treating progressive forms of MS. In a previous study, ibudilast did not reduce relapses or MRI-observed new lesions in a phase II trial involving people with relapsing MS. However, some evidence that this agent could protect the nervous system from damage (neuroprotection) was observed, which is why it’s being tested in people with progressive forms of MS. (Neurology 2010;74:1033).
Eligibility and Details: Participants are people between the ages of 21 and 65 who are diagnosed with secondary-progressive or primary-progressive MS who are currently receiving either glatiramer acetate, interferon beta, or neither treatment. . Further details on inclusion and exclusion criteria are available from the contact below.
Participants will be randomly assigned to receive either oral ibudilast (100 mg/day) or inactive placebo daily for 96 weeks. Treatment will be added to existing glatiramer or interferon treatment in patients currently taking those therapies. The primary outcomes being measured are changes in brain tissue volume loss (determined through MRI scans) and safety/tolerability. Secondary outcomes being measured include further imaging outcomes, progression as measured by the EDSS disability scale, quality of life, cognitive function, and pain.
Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please contact the study site nearest you, as listed on clinicaltrials.gov.
Sites will be enrolling in the following cities:
Kansas City, KS
Los Angeles, CA
New York, NY
Salt Lake City, UT
St. Louis, MO
Stony Brook, NY